In2Bones P02 00281Recalls & reported problems
In2bones · DIAM 2.7 MM DRILL BIT AO ATTACHMENT NON STERILE · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03760225718674), received between Sep 19, 2025 and Sep 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025Break; Break
THE NEOFUSE PLATING SYSTEM IS A UNIQUE PLATING SYSTEM FOR ANKLE FUSION PROVIDING A HIGH STABILITY AND RIGID FIXATION. THE SYSTEM IS COMPOSED OF AN ANATOMICALLY CONTOURED PLATE, WITH A DISTAL PART ADAPTED TO THE TALAR NECK, AND A PROXIMAL PART ADAPTED TO THE DISTAL TIBIAL EPIPHYSIS AND DIAPHYSIS. THE MOST PROXIMAL TIBIAL HOLE IS AN OBLONG HOLE, WHICH FACILITATES PEROPERATIVE HANDLING OF THE PLATE BY THE SURGEON AS IT ENABLES ITS TEMPORARY FIXATION TO THE BONE. RIGID FIXATION IS ACHIEVED BY: THREE 3.5MM DIAMETER SURFIX TYPE LOCKING SCREWS FOR TALAR FIXATION. FOUR 4.5MM DIAMETER SURFIX TYPE LOCKING SCREWS FOR TIBIAL FIXATION. AN ADDITIONAL 4.5MM INTERFRAGMENTARY SCREW (TRANSFOCAL SCREW) TO ENHANCE COMPRESSION OF THE TIBIO-TALAR JOINT, UP-TO THE SUBTALAR JOINT IF NEED BE. THIS CORTICAL SCREW IS INSERTED IN AN OBLIQUE WAY TO REACH THE POSTERIOR ASPECT OF THE TALAR BODY, OR ELSE THE POSTERIOR ASPECT OF THE CALCANEUS, SHOULD THE SURGEON WISH A COMPLEMENTARY SUBTALAR COMPRESSION. AS AN ADDS-ON TO THIS PLATE AND SCREW SYSTEM, IN2BONES HAS DEVELOPED A TARGETING DEVICE THAT ENABLES THE PRECISE POSITIONING OF AN I.B. S® 6.5MM SCREW, APPLIED POSTERIORLY THROUGH THE TIBIOTALAR JOINT, TO ENSURE T
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23094935 ↗
Other BIT, SURGICAL devices
- Tornier Perform MWJ127Tornier, Inc. · BIT, SURGICAL114 reports
- NA 310.534Synthes GmbH · BIT, SURGICAL64 reports
- NA 4200355042Stryker Corporation · BIT, SURGICAL34 reports
- ACUFEX 72204044Smith & Nephew, Inc. · BIT, SURGICAL25 reports
- NA 03.168.011Synthes GmbH · BIT, SURGICAL20 reports
- ACUFEX 72204042Smith & Nephew, Inc. · BIT, SURGICAL19 reports
- ACUFEX 72204046Smith & Nephew, Inc. · BIT, SURGICAL16 reports
- ACUFEX 72204045Smith & Nephew, Inc. · BIT, SURGICAL14 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.